(24 days)
The Gel Mark V is intended to radiographically and sonographically mark breast tissue during a percutaneous breast biopsy procedure.
Not Found
This document is an FDA 510(k) clearance letter for the 'Gel Mark V Biopsy Site Marker' as a substantially equivalent device. It does not contain the acceptance criteria or a study that proves the device meets specific performance criteria.
Therefore, I cannot provide the requested information. The document focuses on regulatory clearance based on substantial equivalence to a predicate device, rather than detailed performance study results against specific criteria.
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right.
Public Health Service
FEB = 7 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Amy Boucly Director, Regulatory Affairs and Quality Assurance SenoRx, Inc. 11 Columbia, Suite A Aliso Viejo, California 92656
Re: K050090
Trade/Device Name: Gel Mark V Biopsy Site Marker Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable clip Regulatory Class: II Product Code: NEU Dated: January 13, 2005 Received: January 14, 2004
Dear Ms. Boucly:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becared the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass stated in the encrease in the enactment date of the Medical Device Amendments, or to conninered pror to they 2013 773) in accordance with the provisions of the Federal Food, Drug, de rices that have boon require approval of a premarket approval application (PMA). and Cosmeter Free (110) has the device, subject to the general controls provisions of the Act. The r ou may, ater sever in one of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is exassinou controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean f that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or any I with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Ms. Amy Boucly
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N Millman
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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SenoRx Inc. Special 510(k) Device Modification Gel Mark™ V Biopsy Site Marker
Indications for Use Statement
| 510(k) Number (if known) | K030090 |
|---|---|
| Device Name | Gel Mark V Biopsy Site Marker |
| Indications for Use | The Gel Mark V is intended to radiographically and sonographically mark breast tissue during a percutaneous breast biopsy procedure. |
Prescription Use X (Per 21 CFR 801. 109)
OR
Over-The-Counter Use
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation
Mark A Wilkerson
(Division Sign-Off) Division of General, Restoration 2011 Neurological Devices
510(k) Number K050096
January 13, 2005
§ 878.4300 Implantable clip.
(a)
Identification. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.